United States Pharmacopoeia Xix defines a unit-dose container as a single-unit container so designed that the contents are administered to the patient as a single dose, direct from the container. A single-unit container is defined as one that is closed in such a manner than none of the contents may be removed without obvious destruction of the closure, the contents of which are intended for use promptly after it is opened. Accordingly, each compartment of a single-unit container must meet the above definitions in order to be used in compliance with current federal regulations.
One type of unit-dose container which is currently available permits a pharmacist to place the unit dosages in the individual compartments and to seal the same therein (such containers are commonly referred to in the market as punch cards or bingo cards). A nurse simply breaks the seal on the individual pocket when the dosage is to be administered. Although this packaging has been generally successful, the removal of medication from an individual compartment requires potentially destructive pressure to be exerted against the medication in order to force the medication through the perforated seal on the opposite side of the compartment. Further, the required pressure to be exerted by a healthcare professional for medication dispensement may over time contribute to such professional developing various adverse health conditions such as carpal tunnel syndrome. Furthermore, the slits in the compartment seals may permit the undetected removal of certain forms of medication and finally, the outer shell of that container requires a paper seal or other adhesive means to prevent removal of the entire compartment containing insert therefrom.
An additional form of unit-dose container disclosed in the prior art is one in which the cover assembly for the individual compartments is simply frictionally held in place with no positive locking of the covers onto the compartments. Such design is unsatisfactory for it does not prevent the undetected removal of medication for medication may be removed and the cover replaced without detection.
The assignee of the instant invention has previously patented many types of cover assemblies for medication dispensers including a plurality of individual covers connected together by fracturable links. Each of the compartment covers includes an integral fracturable tab designed to be independently snap-fitted onto the container to hold the lines in place and to provide a secure and tamperproof closure of each compartment. In some of the fracturable links, the separation of the link from the remainder of the cover was enhanced by the utilization of a notch formed in the tab positioned adjacent the juncture of the tab to the cover top plate. For example, see U.S. Pat. Nos. 4,372,445; 4,735,318; 4,741,441; and 5,011,018.
Although the tabs of the earlier patents identified hereinabove did fracture in a satisfactory manner, there is a perception in the field that the covers of the prior art may be slightly raised, without fracturing the tab, so that medication may be removed from the compartment and then replaced in the compartment without detection. Further, there is the perception in the field that a cover may be removed from its compartment by fracturing the tab thereon with the cover then being able to be replaced on its compartment without the fracturing being visible. For example, if medication is returned to a pharmacy, the pharmacy must check each individual cover to ascertain if the cover has been fractured since the same is not readily perceptible or the medication must be discarded as a safety precaution.
Although Applicants believe that the aforementioned perception is in error, Applicants present invention is directed to address and correct such perception. Further, plastic manufacturers continue to modify the plastic used for constructing the covers. For example, polymer manufacturers have developed polymers which yield more flexible covers which are more difficult to fracture. For example, users are required to exert more pressure in order to fracture the cover. Consequently, such modifications require the lids to be re-designed in order to allow for tolerance in the plastic and to minimize the amount of pressure that a user must exert in order to fracture the cover.
Therefore, it would be desirable to configure a unit-dose container which was designed to positively prevent medication tampering.